SUPPLY CHAIN ARTICLES

  • What Violin Making Can Teach Us About mRNA Therapeutic Quality

    Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.

  • “Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA

    It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).

  • ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.

  • From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

    In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

  • Multidisciplinary mRNA: What Can We Learn From Other CGTs?

    Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.

  • A "Hot Take" on Personalized mRNA Medicines

    mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.

SUPPLY CHAIN VIDEOS

In this final segment of an Advancing RNA Live discussion, panelists April Sena, Tyler Goodwin, and Adi Nair share the most meaningful and manageable improvements the industry can be making today to upstream and downstream processes to drive down mRNA-LNP COGS.In this final segment of an Advancing RNA Live discussion, panelists April Sena, Tyler Goodwin, and Adi Nair share the most meaningful and manageable improvements the industry can be making today to upstream and downstream processes to drive down mRNA-LNP COGS.

We all know that plasmid quality is foundational in dictating the quality of the final mRNA drug substance. In this clip homing in on upstream process considerations, speakers Stu Sundseth (Tune Therapeutics), Marc Wolfgang (Sail Biomedicines), and Christian Dohmen (Ethris) outline some of the most important CQAs for plasmids and the impact they can have on the resulting quality of the mRNA drug substance for linear mRNA. 

In response to an audience poll question gauging which cGMP materials have proven the most difficult to source, our speakers provide additional clarity around which IVT & LNP-related materials today are more “commoditized”.

With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS